Ghost of Vioxx Still Haunts Merck

It’s been nearly four years since Merck pulled its painkiller Vioxx off the market, but the shadow of the drug is still haunting the company from beyond the grave.

This week’s JAMA lands with one article that says some published studies of the drug were actually written by uncredited ghostwriters hired by the company, and a second piece arguing that Merck didn’t appropriately report mortality data from two studies of Vioxx in Alzheimer’s patients.

On the use of a ghostwriter, JAMA editor Catherine DeAngelis told the New York Times, “I consider that being scammed” because the authors didn’t fully disclose the ghostwriter’s role.

Merck, for its part, has fired back with a statement that says many of the comments in the JAMA papers “are false, misleading or lack context.”

Based on court documents and published Vioxx studies, the authors of the ghostwriting study conclude that articles on Vioxx published in medical journals “were frequently authored by Merck employees but attributed first authorship to external, academically affiliated investigators.” And review articles on Vioxx “were frequently prepared by unacknowledged authors employed by medical publishing companies,” write the authors, academic physicians who have consulted for plaintiffs lawyers in the Vioxx litigation.

Merck argues that the academic authors were more involved with the writing than the article suggests. “The outside authors of the papers about Merck’s clinical trials referenced in the JAMA article were intimately involved in the studies,” Peter Kim, president of Merck Research Laboratories said in a statement.

The second article looks at two Alzheimer’s studies in which patients taking Vioxx had a higher rate of death than patients who took placebos, according to an analysis commonly performed on such data. But Merck used a different type of analysis in reporting the results to the FDA, “an approach that minimized the appearance of the mortality risk,” write the authors, one of whom consulted for plaintiffs lawyers in the Vioxx litigation.

What’s more, one of the studies did not have a data safety monitoring board, a common mechanism in clinical trials where outside experts keep an eye on the study for signs of safety problems.

Merck says it analyzed the cause of death in the studies, and found that some were caused by car accidents and other issues not related to the drug. Overall, the company says, “there was no pattern suggesting the deaths had any connection to Vioxx.” A Merck lawyer told the WSJ that the study that did not have a data safety monitoring board did not need one, because it was launched after the drug had already been studied extensively.

In an editorial accompanying the papers, DeAngelis and her deputy call for reforms ranging from disclosing all contributions from people who are involved with the manuscript but not listed as authors, to having physicians forgo paid positions on industry speaker’s bureaus.

“The profession of medicine, in every aspect — clinical, education, and research — has been inundated with profound influence from the pharmaceutical and medical device industries,” the authors write. “This has occurred because physicians have allowed it to happen, and it is time to stop.”

Comments (5 of 25)

I agree with comments from The documents dont lie. I am a caregiver for my mother who suffered two strokes after taking Vioxx more than 18 months. Before the strokes, She was vital, vigorous, healthy and alive. She lived alone and did her own yard and worked. No one in her family background had any genetic dispositions toward strokes. She was not overweight or sick. She had arthritis and took Vioxx. She became totally dependent upon her daughters for care, could not feed herself, could not talk, could not live alone, could not dress or bath herself. Her life was taken from her before it was time. As far as I'm concerned, all of the large companies are greedy and after money and money takes precedent over people. God knows the truth and He will make sure justice is served on those who are corupt and put their pocket books before the life of a person. God values life not money. No amount of money will restore what has been taken from my mother or my sister and I. My mother died this January and I have absolutely no sympathy with stockholders or liars, or those who manipulate the truth. God is truth and I pray the truth be revealed for what it really is.

9:17 pm April 17, 2008

Anonymous wrote :

hi, paper are just records, they don;t lie but they can be true or errors, you are playing debating games here. I am just an audience but I don;t like your logic.

5:18 pm April 17, 2008

The documents don't lie wrote :

Notwithstanding Merck's denials, the alleged bias of the article writers - the internal company documents don't lie -- the internal company emails between ths scientists, executives and markets don't lie. The truth lies in the paper trail. Merck lost its way. It was once run by a physican but then was turned over to a Harvard Business man and it was on his watch that the Vioxx debacle unfolded. Science and marketing don't mix but they were mixed. Merck needed Vioxx - most of its primary money makers were about to go generic because their patents were going to expire. Internal company emails from executives, top level executives like Ed Scolnick - confirm the desperation in the race to market with Celebrex. Again -the Emails don't lie. They know of the risk or heart attack and stroke early on - their own company documents don't lie. Then they came up with the so called "Naproxen theory." Oh, its not our Vioxx that caused a 5 x increase in heart attacks - its Naproxen's cardioprotecitive effect. Has anyone ever taken Naproxen to protect against a heart attack. Of course not! If there was any proof that Naproxen was in any way cardioprotective - believe me - we'd be seeing commercials from the Naproxen makers saying as much. The Naproxen theory was a manufactured false self-delusional bogus justification to keep a drug on the market to make more money. Gilmarten, Scolnick and worst of all Alise Reicin had one thing in mind - Merck's stock price. Indeed Reicin's own brother is a financial analyst on WallStreet. Querey the conflict of interest there....
Now back to the documents that don't lie. After their own trial, VIGOR, showed a 5 x increase in heart attack - their own documents reflect they cancelled the planned heart attack (CV) study Valor. Flat out did not do it. Scolnick himself in an email said that a CV study was the "the one essential study." Again the paper does not lie. So what do they do with the results showing 5 x increase risk in heart attacks - their own documents reflect that they trained their Sales Reps to "Dodge" physicians questions about the heart attack risk. Can you believe that there was actually a sale rep training documents produced in the litigation called "Dodge Ball Vioxx" used to train Representatives how to respond to or “dodge” certain questions and concerns that doctors might have about Vioxx. The game includes a 12-page list of obstacles or questions concerning the association between Vioxx and certain risks including CV risk -- “I am concerned about the cardiovascular effects of Vioxx.” The 12 pages of obstacles are flanked by two pages that exclaim “Dodge!” It is not only their documents where the truth lies but its videotape. For instance, sales training videotapes such as the "V-Squad Video," a video provided to District Managers which taught Representatives that Vioxx did not increase the risk of heart attacks. The videotape depicts actors playing Merck Representatives avoiding questions from physicians or “obstacles” about Vioxx's potential to increase blood pressure - a documented side-effect. Then later in the video an actress playing "an obstacle" to Vioxx sales distressingly states, "I'm afraid Vioxx causes MIs" and in response, an actress playing a Merck Representative says, "That's not true." This videotape and other documents reflect that physicians’ question about Vioxx’s CV risk were called, and treated as, “obstacles” to be avoided or dismissed by Merck’s Representatives. Representatives were trained and used promotional (detail) pieces with physicians that were expressly designed to neutralize a physicians' concerns about Vioxx’s CV risk. For instance, the “Cardiovascluar Card.” Black-and-white copies of the CV Card and other detail pieces have been found in custodial files. When a physician asked about certain Vioxx risk, including the CV and others, Merck Representatives were instructed to refer to the glossy color tri-fold "Cardiovascular Card" that set out data suggesting that Vioxx could be safer than other anti-inflammatory drugs. Yet the CV Card failed to include the anything about the VIGOR study results. The CV Card is an obstacle handling piece," according to the April 2000 Bulletin distributing it to Merck’s sales force to “. . . to set the record straight with your physicians." Once again - the truth lies in the documents. Does anyone remember when Merck was called on its "Dine and Dash" Program. Dine-n-Dash program. The alleged purpose of the program was to provide physicians with medical information. However, not much education occurred because with the “Dash,” physicians could show-up at a restaurant, pick up meals (and Vioxx literature) and leave without listening to the scheduled speaker. It was not until “Dine-n-Dash” was brought to the public’s attention in a stinging Wall-Street Journal article that Merck decided to cancel the program. Again, this is not a company concerned about science but sales. The bottom line is this - Merck employees may not like the facts but the facts come from a paper trail. It is not the lawyers that create the paper trail or Emails - they discovery them. Get back to science and put people first Merck.

1:00 pm April 17, 2008

Anonymous wrote :

I see many angry comments here, seems from merck people. If you think you are right, then why didn't you file lawsuits against these people? why did you pay the 5 billion settlement?
just be curious.

8:38 pm April 16, 2008

shareholder underwater wrote :

Merck PR is horrendous. You won the VIOXX battle but are losing the PR war. Hire some professionals please besides good lawyers. Marketing/PR groups may want to focus on the company and the industry, instead of promoting weakened drugs.